Neurofeedback Study ADHD

November 14, 2016 updated by: Winfried Rief, Philipps University Marburg Medical Center
Neurofeedback has proved to be effective in treating Attention deficit hyperactivity disorder (ADHD) in experimental settings. This study investigates whether neurofeedback can be used as a therapeutic intervention in regular outpatient care. The investigators compare high frequent neurofeedback with high frequent self-management therapy and suppose that both result in comparable effects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Marburg, Hessen, Germany, 35037
        • Recruiting
        • Philipps-University Marburg, Department of Psychology, Clinical Child and Adolescent Psychology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hanna Christiansen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children with ADHD aged 7 to 11
  • full command of the German language.

Exclusion Criteria:

  • IQ below 80

Children with symptoms of:

  • inattention,
  • hyperactivity or

  • impulsivity due to other medical reasons such as:

    • hyperthyreosis,
    • autism,
    • epilepsy,
    • brain disorders and
    • any genetic or medical disorder associated with externalizing behavior that mimics ADHD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neurofeedback with Psychoeducation (NF + PE)
Neurofeedback plus Parental Psychoeducation
Behavioral: NF
Behavioral: PE
Active Comparator: Self-Management with Psychoeducation (SM + PE)
Self-management + parental psychoeducation
Behavioral: PE
Behavioral: SM
Active Comparator: NF+PE and additional Social Support (SU)
Neurofeedback + parental psychoeducation enhanced with social support
Behavioral: NF
Behavioral: PE
Behavioral: SU
Active Comparator: SM+PE and additional Social Support (SU)
Self-management + parental psychoeducation enhanced with social support
Behavioral: PE
Behavioral: SM
Behavioral: SU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core ADHD symptoms (inattention/hyperactivity/impulsivity) objectively assessed with the computer based Qb-Test (go-no-go-task with infrared camera)
Time Frame: Pre-Post-Change-Design; change for core symptoms from baseline to after 12 weeks, 6 and 12 months

Children perform the Qb-Test:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change for core symptoms from baseline to after 12 weeks, 6 and 12 months
Conners Psychopathology Scores
Time Frame: Pre-Post-Change-Design; change from baseline to psychopathology scores after 12 weeks, 6 and 12 months

Conners parents & teacher rating scales:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to psychopathology scores after 12 weeks, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Support
Time Frame: Pre-Post-Change-Design; change from baseline to social support scores after 12 weeks, 6 and 12 months

Children's social support scale:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to social support scores after 12 weeks, 6 and 12 months
Self-Concept
Time Frame: Pre-Post-Change-Design; change from baseline to self-concept scores after 12 weeks, 6 and 12 months

Children's self-concept interview:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to self-concept scores after 12 weeks, 6 and 12 months
Perceived Criticism
Time Frame: Pre-Post-Change-Design; change from baseline to perceived criticism scores after 12 weeks, 6 and 12 months

Assessment of children's perceived criticism:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to perceived criticism scores after 12 weeks, 6 and 12 months
Parental Stress (ESF)
Time Frame: Pre-Post-Change-Design; change from baseline to parental stress scores after 12 weeks, 6 and 12 months

Parent Stress Questionnaire:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to parental stress scores after 12 weeks, 6 and 12 months
Cortisol
Time Frame: Pre-Post-Change-Design; change from baseline to cortisol levels after 12 weeks, 6 and 12 month

Assessed with hair-samples:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to cortisol levels after 12 weeks, 6 and 12 month
Blood/saliva samples for possible genetic correlates of therapy response
Time Frame: End of therapy after 36 sessions
Either saliva sampling or blood samples for genotyping of ADHD candidate genes to establish possible correlates of therapy response
End of therapy after 36 sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philipps University Marburg Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NF-HC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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